ISO 9000 specifies requirements for a Quality Management System overseeing the production of a product or service. It is not a standard for ensuring a product or service is of quality; rather, it attests to the process of production, and how it will be managed and reviewed.

ISO 9000 was originally created by the British Standard Institute as BS 5750. The standard is now maintained by ISO (the International Organization for Standardization) and administered by accreditation and certification bodies

ISO does not itself certify organizations. Its national members act as accreditation bodies to authorize certification bodies, which audit organizations applying for ISO 9000 compliance certification. Both the accreditation bodies and the certification bodies charge fees for their services.

The applying organization is assessed based on an extensive sample of its sites, functions, products, services, and processes and a list of problems ("action requests" or "non-compliances") made known to management. If there are no major problems on this list, the certification body will issue an ISO 9000 certificate for each geographical site it has visited once it receives a satisfactory improvement plan from the management showing how any problems will be resolved.

An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body — usually around 3 years.

Two types of auditing are required by the standard: auditing by the external certification body and audits by internal staff trained for this process. The aim is a continual process of assessment, leading to corrective and preventive actions, is maintained throughout the scope of the certified organization. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments.

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